The repair of body wall defects and hernia defects is well known in the surgical arts. In a body wall defect, in particular a hernia defect, a defect or opening in the body wall allows the inner peritoneum to protrude through the defect forming a hernia sack. Typically, a section of the patient's viscera will protrude through the body wall and is contained within the hernia sack. Although a patient may live with such a body wall defect without any medical intervention, it is known that complications associated with such a condition may arise. First of all, from an aesthetic perspective the bulge associated with the hernia may be relatively unsightly. Secondly, since a section of viscera may protrude through the defect, there is a possibility of strangulation of the protruding section of viscera caused by the musculature surrounding the defect resulting in potential necrosis of the visceral section, typically a section of intestine. In addition, if untreated the hernia defect may grow in size over time, restricting the patient's activities. And, the patient may experience pain and other physical symptoms.
In order to repair a hernia defect, or other body wall defect, a surgical procedure is necessary. The procedure may be open (direct visualization) or closed (indirect visualization), i.e., endoscopic. Although a hernia defect can be surgically repaired by suturing the tissue surrounding the defect together, i.e., approximating the tissue, it is generally accepted that this type of repair may result in long term recurrence of the hernia. The prevailing standard of care for many hernia repair procedures is to implant a surgical mesh over the body wall defect. During the healing process post-implantation, tissue infiltrates into the mesh and the mesh is essentially incorporated into the body wall and serves as a reinforcing structure. In ventral hernia procedures, the mesh implant may be affixed directly to the peritoneum or may be affixed to fascial tissue above the peritoneum. The hernia mesh implants are typically mounted using specially designed surgical tacks and tacking instruments. In addition to using tacks, many surgeons have a preference for additionally mounting stay sutures to a mesh implant. The stay sutures are used to locate the mesh over the body wall defect prior to securing the mesh implant in place with tacks. The stay sutures serve a dual function of initially aiding in the proper positioning of the mesh implant and providing a second level of tissue securement over and above the securement provided by the tacks.
During a typical hernia repair procedure, a suitably sized hernia mesh implant is selected by the surgeon. The implant must be trimmed in the operating room to the appropriate size to effectively provide a support function while minimizing the amount of mesh (i.e., the mass) implanted in the patient. After trimming the mesh implant, the surgeon must then mount the stay sutures to the mesh implant, typically along axes at four opposed sides of the implant (i.e., north-south and east-west). This is a time consuming process requiring the application of multiple surgical knots for each mounted suture, and resulting in knot tower. The surgeon then locates the mesh implant at the appropriate location over the hernia defect using the stay sutures, and each stay suture is pulled through and mounted in the overlying body wall tissue using a standard suture passer/retrieval instrument.
Since conventional hernia mesh implants are provided by the manufacturers in standard sizes and typically rectangular configurations, the mesh implants must be trimmed by the surgeon in the operating room prior to implantation in order to customize and conform the mesh implants to an individual patient's hernia defect and anatomy. This precludes the manufacturer from providing mesh implants with pre-mounted stay sutures. There is a need in this art for novel stay suture devices which are quickly and readily mounted to trimmed hernia mesh implants by the surgeon in the operating room.